Quality & Compliance

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One Quality System – Two Manufacturing Plants

Corporate SOPs to govern two manufacturing plants consistent with Q7
Site SOPs specific to each locations operations
Chemists specifically trained for manufacturing under cGMP
QA/QC staff at both manufacturing plants
QC testing and QA release of all raw materials
Production Batch Records in English at both sites
Qualified facility, utilities and equipment
QA physical control of documents and drug substance
Seasoned Quality staff; over 40 QA staff and consultants who all have established PAI experience

Quality Control Laboratory

HPLC
Karl-Fischer
GC
LC/MS/MS
UV/Vis
FTIR
pH meter
Peptide sequencer
Melting point apparatus
Endotoxin and bioburden
Stability Chambers

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